CN105727267B - Recombinant human hyaluronidase freeze-dried preparation and preparation method and application thereof - Google Patents
Recombinant human hyaluronidase freeze-dried preparation and preparation method and application thereof Download PDFInfo
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- CN105727267B CN105727267B CN201610081945.XA CN201610081945A CN105727267B CN 105727267 B CN105727267 B CN 105727267B CN 201610081945 A CN201610081945 A CN 201610081945A CN 105727267 B CN105727267 B CN 105727267B
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- recombinant human
- human hyaluronidase
- preparation
- hyaluronidase
- freeze
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- 229940120723 recombinant human hyaluronidase Drugs 0.000 title claims abstract description 50
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- 239000004094 surface-active agent Substances 0.000 claims abstract description 13
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- 238000007710 freezing Methods 0.000 claims abstract description 5
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- 229910001628 calcium chloride Inorganic materials 0.000 claims description 6
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Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
- C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
- C12Y302/01035—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
Abstract
Description
Procedure for the preparation of the | Set sheet temperature (. degree. C.) | Retention time (hr) | Set vacuum degree (mbar) |
(1) Prefreezing | -5 | 1.0 | |
(2) Prefreezing | -40 | 3 | |
(3) Drying | -25 | 19.5 | 15 |
(4) |
0 | 2.0 | 15 |
(5) Drying | 25 | 8.5 | 15 |
G | H | I | |
Hyaluronidase | 1800000IU | 1800000IU | 1800000IU |
Tween 20 | 1.2g | 1.2g | 1.2g |
Mannitol | 180g | 240g | 300g |
Sucrose | 120g | 120g | 120g |
Disodium hydrogen phosphate | 8.4g | 8.4g | 8.4g |
Ethylenediaminetetraacetic acid disodium salt | 5.4g | 5.4g | 5.4g |
Calcium chloride | 1.8g | 1.8g | 1.8g |
Claims (7)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN201610081945.XA CN105727267B (en) | 2016-02-05 | 2016-02-05 | Recombinant human hyaluronidase freeze-dried preparation and preparation method and application thereof |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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CN201610081945.XA CN105727267B (en) | 2016-02-05 | 2016-02-05 | Recombinant human hyaluronidase freeze-dried preparation and preparation method and application thereof |
Publications (2)
Publication Number | Publication Date |
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CN105727267A CN105727267A (en) | 2016-07-06 |
CN105727267B true CN105727267B (en) | 2020-05-26 |
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CN201610081945.XA Active CN105727267B (en) | 2016-02-05 | 2016-02-05 | Recombinant human hyaluronidase freeze-dried preparation and preparation method and application thereof |
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CN (1) | CN105727267B (en) |
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EP4017524A4 (en) * | 2019-10-15 | 2022-09-21 | Standard of Care Corporation | Compositions comprising hyaluronidase and/or collagenase and/or 4-methylumbelliferone (4-mu) and methods of treatment using same |
CN114250212A (en) * | 2021-12-14 | 2022-03-29 | 华熙生物科技股份有限公司 | Hyaluronidase freeze-dried preparation and preparation method thereof |
CN114010528B (en) * | 2021-12-20 | 2023-09-15 | 广州栋方生物科技股份有限公司 | Recombinant human collagen freeze-dried powder and preparation method thereof |
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